Efficacy and Safety of MTX-loaded Nanoparticles to Treat Severe COVID-19 Patients

• Status: Not yet recruiting
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the efficacy and safety of MTX-loaded nanoparticles in three different doses to treat severe COVID-19 patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Collaborators: Hospital Santa Marcelina; InCor Heart Institute; Prevent Senior Institute; PREVENT SENIOR PRIVATE OPERADORA DE SAÚDE LTDA
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

1. Informed consent from patient or legal representative.

2. Male or female, aged ≥ 18 years;

3. Acute respiratory distress syndrome; with imminent risk of death, and with chest CT scan with pulmonary impairment greater than 50%;

4. Confirmed or pending diagnosis of COVID-19.

Exclusion Criteria:

1. Pleural effusion > 150mL or ascites > 200mL;

2. Chronic liver disease;

3. ALT and AST serum levels >= three times the upper limit of normality;

4. Renal failure (dialysis)

5. Multiple organ failure

7. Concomitant use or use in the last 7 days of cell therapy with stem cells; 8. Any clinical or laboratory condition or comorbidity that, at medical discretion, 9. Known hypersensitivity to the investigational product; 10. Subject who is pregnant or lactating